Common use of Process Development Programs Clause in Contracts

Process Development Programs. (a) The Development Management Committee shall decide which process technologies—e.g., hybridoma, recombinant, Cell: Cell Fusion—shall be used in the Process Development Program for each lead Research Antibody and Candidate Drug. AZ shall have the sole right to make decisions regarding (x) the use of any Third Party royalty bearing technology Controlled by ABX, and the in-licensing of Third Party intellectual property in connection with the use of technologies that are not already Controlled by ABX or that are specific to such Research Antibody and Candidate Drug, and (y) without limiting the obligation of AZ to purchase (and ABX to supply) AZ’s requirements of each of its Research Antibodies and Candidate Drugs from ABX as provided herein [Confidential treatment requested], the need for any backup facility, and selection, qualification and use of any Third Party manufacturing facility for each such Research Antibody and Candidate Drug. The Parties acknowledge and agree that (i) the decision to commence a Process Development Program should take into consideration the likelihood that an Antibody will be designated a Candidate Drug, (ii) it may be necessary or useful to simultaneously pursue the development of multiple process technologies for a particular Candidate Drug based on scientific, technical, intellectual property or commercial considerations, (iii) the process technology used to manufacture early clinical supplies of a Candidate Drug may be different than the process technology used to manufacture later stage clinical and commercial supplies of such Candidate Drug or the applicable Licensed Product, (iv) the Parties intend that the process technology and the facility (or facilities) to be used to manufacture a Licensed Product for Phase III Clinical Trials will be the same as that used for commercial supply, (v) the Process Development and Manufacturing Plan for each Licensed Product will include reasonable plans for fully-qualified back-up manufacturing facilities to provide for uninterrupted supply upon the occurrence of a Force Majeure event or increased product requirements beyond the quantities that ABX is able to supply, and (vi) the Process Development and Manufacturing Plan for each Licensed Product will include a plan for technology transfer to AZ (or its designee) in accordance with Section 7.10. (b) The process development work conducted by or on behalf of ABX under the Process Science/Clinical Manufacture Agreement for each Process Development Program shall, for example, include the following: (i) establishment of product specifications for finished, formulated bulk and vialed form of the Candidate Drugs and Licensed Products; (ii) cell line development and optimization; (iii) development and characterization of a research cell bank and a master cell bank; (iv) cell culture development and purification process (using the manufacturing process technology(ies) designated by the Development Management Committee) for producing each Candidate Drug and Licensed Product using such master cell bank; (v) performance of appropriate qualified, and when necessary validated, assays to quantify the biochemical, immunological and functional characteristics of each Candidate Drug and Licensed Product produced; (vi) performance of stability studies; (vii) release of each Candidate Drug and Licensed Product; and (viii) development of a transferable and scalable cGMP process for each Candidate Drug and Licensed Product to enable AZ or its designee (subject to Sections 7.2.2(b) and 7.3) to manufacture clinical and commercial grade materials (including sufficient clinical and commercial quantities thereof).